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In light of recent evidence, olanzapine (Zyprexa) has been FDA approved as an effective monotherapy for the maintenance of bipolar disorder. [22] A head-to-head randomized control trial in 2005 has also shown olanzapine monotherapy to be just as effective and safe as lithium in prophylaxis. [23]
Lumateperone was approved for medical use in the United States in December 2019 with an initial indication for schizophrenia, [4] [5] and became available in February 2020. [2] It has since demonstrated efficacy in bipolar depression and received FDA approval in December 2021 for depressive episodes associated with both bipolar I and II disorders.
Cariprazine is used to treat patients with schizophrenia and manic, depressive, or mixed episodes associated with bipolar I disorder.In the United States it is approved for schizophrenia in adults, acute treatment of manic or mixed episodes associated with bipolar I disorder in adults and treatment of depressive episodes associated with bipolar I disorder (bipolar depression).
FDA approved for bipolar disorder maintenance therapy, not for acute mood problems like depression or mania/hypomania. [10] The usual target dose is 100–200 mg daily, titrated to by 25 mg increments every 2 weeks. [11] Lamotrigine can cause Stevens–Johnson syndrome, a very rare but potentially fatal skin condition. [10] Carbamazepine
In 2013, it was approved in Canada and by the U.S. Food and Drug Administration (FDA) to treat bipolar depression, either as monotherapy or adjunctively with lithium or valproate. [15] [16] It has no effect on manic symptoms and is more potent for treating major depressive disorder or depressive episodes associated with bipolar disorder ...
The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in people who have not responded to at least two oral antidepressants.
Asenapine has been approved by the FDA for the acute treatment of adults with schizophrenia and acute treatment of manic or mixed episodes associated with bipolar I disorder with or without psychotic features in adults. [12] In Australia asenapine's approved (and also listed on the PBS) indications include the following: [14] Schizophrenia
The US FDA accepted Eisai’s Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025. Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product ...